Elan Pharma International Limited

Klan Pharma International Ltd.

Linden Wei

Rajeev A Jain

Elaine Liversidge

Jon Swanson

Greta A Gottardy

The present invention is directed to methods for preventing crystal growth and particle aggregation in nanoparticulate compositions. The methods comprise reducing a nanoparticulate composition to an optimal effective average particle size. The resultant nanoparticulate compositions exhibit prolonged particle size stability and minimal crystal growth, even following exposure to elevated temperatures.

Methods for preventing crystal growth and particle aggregation in nanoparticulate compositions

Described are solid dose nanoparticulate naproxen formulations having high rates of dissolution. The solid dose nanoparticulate naproxen formulations can comprise an alkali compound, which functions to increase the dissolution rate of the naproxen following administration. Alternatively, the solid dose nanoparticulate naproxen formulation can comprise an alkali compound and an acidic compound, which can react together to form carbon dioxide. The formed carbon dioxide can also aid in increasing the dissolution rate of the naproxen following administration. Also described are solid dose nanoparticulate naproxen formulations having a decreased concentration of a binder/disintegrant agent. Such compositions also provide an increased rate of dissolution of naproxen following administration.

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Exton, PA, United States of America

Linden Wei